Kornimate/medical-research-clean huggingface dataset:
exercise capacity in pediatric sickle cell anemia

Conditions: Sickle Cell Anemia

Summary: the purpose of this study is to use comprehensive exercise testing to examine causes of exercise limitation in children and young adults with sickle cell anemia.

although the burden of sickle cell anemia (sca) on affected individuals is significant, few studies have examined the influence of having sca on such measures of physical function as exercise capacity. moreover, the physiologic basis of poor physical functioning in children with sca is unknown and has not been studied extensively. the purpose of this proposal is to use cardiopulmonary exercise testing (cpet) to gain a comprehensive understanding of exercise capacity, as a measure of physical function, in children and young adults with sca. the specific aims of this project are to: 1) measure peak oxygen consumption (vo2), the reference standard for exercise capacity, in children and young adults with sca classified by primary pathophysiologic contributor to their decreased exercise capacity, and 2) examine the acute inflammatory response, measured by an increase in soluble vascular cell adhesion molecule (svcam) activity, in subjects undergoing cpet. these aims will be performed in 60 subjects with sca and 30 matched controls without sca. in a secondary analysis, we will also study the impact of baseline exercise capacity and the inflammatory response to exercise on short and long-term disease related morbidity. this study is essential because it will address several areas of exercise capacity, including the physiologic contributors to exercise limitation that remain fundamental knowledge gaps in sca.

Eligibility criteria:
inclusion criteria: 1. age 10 to 21 years old; and 2. hb ss or s-β0 thalassemia disease, confirmed by hemoglobin analysis exclusion criteria: 1. inability to perform maximal testing due to physical limitation (e.g. stroke or avascular necrosis); or 2. history of exercise-induced syncope or arrhythmias. subjects will wait at least 2 weeks following any vaso-occlusive pain episode and 12 weeks following any disease-related complication requiring transfusion support. individuals on hydroxyurea will be eligible. a total of 30 controls without sca or sickle cell trait will be matched for age, sex and race and recruited from the siblings, friends or relatives of subjects enrolled on this study

Keywords: sickle cell anemia exercise testing cardiopulmonary disease
treatment of human gingivitis with amnion-derived cellular cytokine solution (accs)

Conditions: Gingivitis

Summary: the purpose of this study is to evaluate the safety of oral topical application of amnion-derived cellular cytokine solution (accs) in subjects with gingivitis

this randomized blinded study will evaluate the use of accs in subjects with gingivitis. two doses of accs will be used. it will be given topically intra-orally daily monday through friday for 2 weeks. in the first cohort, a low dose of accs or saline will be given by random chance. if there are no safety issues, cohort two will include a higher dose of accs randomized with saline. pocket depth, plaque index, gingival index, and bleeding on probing will be assessed. to assess shifts in supragingival flora, a qualitative and quantitative microbial analysis will be performed for common oral bacteria. there will also be an analysis of inflammatory cytokines in crevicular fluid at the beginning and end of the study. comparisons of adverse events and outcomes will be made between the subjects receiving low dose accs, high dose accs, and saline.

Eligibility criteria:
inclusion criteria: * good general health * ages 18-70 years * minimum of 20 natural teeth * modified gingival index score of 2.0 or greater and \>40 percent bleeding sites at initial presentation. exclusion criteria: * presence of orthodontic appliance * soft or hard tissue tumor of the oral cavity * carious lesion requiring immediate treatment * participation in another clinical trial within 30 days * pregnant or breast-feeding women * women of child-bearing potential refusing to use an acceptable method of birth control * antibiotic therapy within the last 30 days * chronic use (\> 3 times/week) of non-steroidal anti-inflammatory medications (nsaid). any use of steroids. low dose (\<325 mg) aspirin is allowed. * immune-compromised subjects * subjects with liver or kidney dysfunction on blood tests as evidenced by a value equal to or greater than 2x the upper limit of normal. * any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues such as diabetes rheumatoid arthritis, crohn's disease, use of nifedipine, phenytoin (dilantin), anticoagulant medications (e.g. warfarin), ongoing cancer treatment either with radiation of chemotherapy.

Keywords: gingivitis periodontitis accs
ultramicronized pea (normast) in spinal cord injury neuropathic pain

Conditions: Neuropathic Pain; Spinal Cord Injury

Summary: randomized, double-blinded, placebo-controlled, parallel group study of ultramicronized pea (normast)600 mg x 2 daily or corresponding placebo with a week of baseline period followed by 1 x 12 weeks treatment period.

study design: randomized, double-blinded, placebo-controlled, parallel, multi-center study of ultramicronized pea (normast)with a week of baseline period followed by 1 x 12 weeks treatment period. methodology: given normast 600mg x 2 daily or corresponding placebo and kept on that dose for 12 weeks.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or more with at- and/or below-level neuropathic pain for at least 3 months due to trauma or disease of the spinal cord or cauda equina (of at least 6 months old) with a mean pain intensity from 4 to 9 on a 0-10 point numeric rating scale (nrs) during a one-week baseline period will be eligible for the study exclusion criteria: * known concomitant severe cerebral damage, terminal illness, planned surgery, pregnancy or lactation, alcohol or substance abuse, hypersensitivity to pea or carrier, and psychiatric disease except depression.

Keywords: neuropathic pain following spinal cord injury
controlling hypertension in diabetes- feasibility study

Conditions: Type 2 Diabetes; Hypertension; Hyperlipidemia

Summary: many primary care patients, especially in inner-city settings, do not achieve targets for blood pressure and glycemic control. there is an urgent need to enhance treatment for those who do not reach goals within the usual clinical care system. we propose to develop a multi-component intervention grounded in the chronic care model, and sustainable in resource-challenged settings. through collaboration with home health nursing and with the use of home telemetry for feedback and intensification of therapy, we will augment usual clinical services to improve health outcomes for diabetes patients who have not been able to reach therapeutic goals. there are three specific aims. first, we will establish a feasible, practical and sustainable collaborative model between the primary care sites of our practice-based research network (nyc ring), clinical researchers at the diabetes research and training center, and the montefiore home health organization, integrating the unique expertise of each of the partners and defining the roles and responsibilities of each. second, we will develop and refine the components of the intervention, to include training primary care providers and home health nurses to integrate the technical, psychosocial and communication processes for implementation of the intervention. third, we will assess the feasibility of the collaborative intervention by implementing the intervention for 25 primary care patients and obtain preliminary estimates of effectiveness by comparing outcomes to 25 patients receiving usual care. our proposal includes plans to develop feasible procedures for data collection, with qualitative and quantitative methods of assessing process and outcome measures. we will use these preliminary data to revise the intervention and prepare an r18 application to further develop and test the intervention in multiple inner-city primary care sites serving low-income diabetes patients. this proposal is for secondary prevention of diabetes complications, targeting a population known for health disparities and a high burden from this chronic disease.


Eligibility criteria:
inclusion criteria: * type 2 diabetes, * bp above 140/90 on two health center visits, * home touch tone phone exclusion criteria: * dementia, * homelessness, * language other than english or spanish

Keywords: type 2 diabetes hypertension health services research health disparities behavior change
nac sparing mastectomy after neo-adjuvant chemotherapy

Conditions: Breast Cancer

Summary: nipple areolar-complex (nac) sparing mastectomy, extending the concept of skin-sparing mastectomy, allows to leave the nipple-areola complex intact and to provide a better cosmetic result. large operable t2-t3 breast cancer (bc), treated with neoadjuvant chemotherapy, may theoretically appear suitable for this surgical option, alternative to conventional mastectomy or breast conserving surgery in case of unfavorable size of the breast, when a good response to neoadjuvant chemotherapy has been achieved.

from january 2009 to may 2013, 422 bc patients were progressively accrued to nac-sparing mastectomy, of which 361 invasive bc patients underwent nac-sparing mastectomy as first treatment (nac-group), whereas 61 t2-t3 invasive bc patients underwent surgery after primary chemotherapy (nac-pc group). 151 bc patients underwent primary chemotherapy and conventional mastectomy (pc group) from 2004 to 2009, has been evaluated as comparative group respect to nac-pc group. using propensity score matching, local disease-free survival (ldfs) in nac-pc patients was first compared with that in pc patients. the nac-pc cohort was then compared to nac patients in terms of ldfs using two different matching criteria, one with tumor size after neoadjuvant chemotherapy and one with tumor size before neoadjuvant chemotherapy as balancing covariates.

Eligibility criteria:
inclusion criteria: t2-t3 n0-n1 breast cancer (nac-pc and pc groups). t1-t3 n0-1 m0 breast cancer (nac-group) in our series of nac-sparing mastectomy patients, with or without treatment with neo-adjuvant chemotherapy, the selection of patients for nac-sparing mastectomy has been made on the basis of the following criterions: tumor nodule without adherence to the skin, no nipple retraction, retroareolar main duct free for neoplastic tissue inside at frozen section examination. furthermore, patients were considered still eligible for nac-sparing mastectomy even if the tumor lies in close proximity (\<1 cm) to the nac at physical and radiological examination. exclusion criteria: (nac-pc and pc groups). exclusion criteria for the present study were all the other breast cancer patients, particularly t4 breast cancer with inflammatory or ulcerated breast cancer before chemotherapy and patients with synchronous distant metastases. patients affected with other clinical diseases (i.e. cardiovascular diseases) conditioning the optimal therapeutic strategy were excluded. for nac-sparing mastectomy, exclusion criterions were nipple retraction, paget's disease, inflammatory changes of the breast and bloody discharge from the nipple. the study did not exclude women with prior breast augmentation, heavy smokers, obese patients. -
study for treatment with th-4000 (tarloxotinib) in epidermal growth factor receptor (egfr) mutant, t790m-negative non-small cell lung cancer (nsclc) patients

Conditions: Non-small Cell Lung Cancer; NSCLC; Non-squamous NSCLC

Summary: this phase 2 study is designed to evaluate the safety and activity of th-4000 a hypoxia-activated prodrug, in patients with egfr-mutant, t790m-negative, advanced nsclc.

a single arm open label multi-center phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of th-4000 will be assessed in patients with egfr mutant, t790m negative advanced nsclc. patients must have demonstrated progression during egfr tki therapy. hypoxia pet scans will be obtained in select centers to analyze potential predictors of tumor response.

Eligibility criteria:
key eligibility criteria: * eastern cooperative oncology group (ecog) performance status 0-1 * confirmed recurrent stage iv nsclc which progressed while on treatment with egfr tki * measurable disease according to response evaluation criteria in solid tumors version 1.1 (recist 1.1) * documented evidence of an egfr mutation known to be associated with an egfr tki sensitivity * no t790m mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent egfr tki therapy * acceptable laboratory results as indicated by protocol * acceptable cardiac function as indicated by protocol key exclusion criteria: * receiving medication that prolongs qt interval, with a risk of causing torsades de pointes (tdp) unless ecg meets inclusion criteria while on a stable dose of the medication * family history of long corrected qt interval (qtc) syndrome * symptomatic central nervous system (cns) lesions * radiation therapy within 2 weeks prior to the first dose of study medication * major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication * concurrent active malignancy requiring systemic treatment * any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus \[hiv\]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures * pregnant or breast-feeding

Keywords: th-4000 low-oxygen conditions hypoxia non-small cell lung cancer nsclc squamous cell carcinoma tarloxotinib
intestinal genes expression associated with necrotizing enterocolitis

Conditions: Neonatal Disease

Summary: in recent days, necrotizing enterocolitis is one of the most common and devastating problem in preterm infants. therefore, it became a high growing research topic in the last decade. the development of medical care increases the survival of preterm babies and consequently increase the number of cases with this serious problem. a systematic review shows the incidence of necrotizing enterocolitis is about 2-7% in babies less than 32weeks gestation and 5-22% in baby's birth weight less than 1000gram.

in 2011, study on average cost of necrotizing enterocolitis in united states shows average cost of health service for preterm baby without necrotizing enterocolitis and with necrotizing enterocolitis 74,004 $-198,040 $ respectively.babies surviving from necrotizing enterocolitis are at risk of long term complication such as short bowel syndrome and intestinal stricture.furthermore, impairment of neurodevelopment and growth are usually observed in these babies.in spite of decades of researches on the disease, pathogenesis of necrotizing enterocolitis still unclear. we still don't know how to prevent and treat the disease. however, advancement of researches in the field of microbiology and cellular biology of the intestine of preterm infants could lead to more understanding for early diagnosis, prevention and proper treatment. enteral feeding in preterm pigs lead to upregulation of inflammatory and pattern recognition receptor genes including interleukin8 and toll like receptor-4 with corresponding condensation of chromatin configuration that lead to initiation of inflammatory process and development of necrotizing enterocolitis. it is not known if these changes are present in human preterm bowel.t cell effector function in preterm infant immune response is characterised by preponderance of interleukin-8 producing t-cells and has the potential to activate neutrophils and γδ t cells.γδ t cells are predominant intra-epithelial lymphocyte in immature preterm gut and has a role in maintaining intestinal integrity.

Eligibility criteria:
inclusion criteria: * cases of necrotizing enterocolitis diagnosed by modified bells criteria, radiological picture and need surgical intervention. exclusion criteria: * cases of severe intrauterine growth retardation. * cases with severe congenital anomalies.
platelet rich plasma versus radio frequency for chronic knee arthritis

Conditions: Osteo Arthritis Knee; Pain, Chronic

Summary: osteoarthritis (oa) affects aged above 45 years. rf has been used for several painful conditions. there have been a few attempts to use rf current for the treatment of painful conditions of joints of the extremities. it was also used for the treatment of painful conditions of the hip joint.


Eligibility criteria:
inclusion criteria: * osteoarthritis knee exclusion criteria: * coaguloapthy * patient refusal
post-poem gerd in patients undergoing conventional versus oblique fibers sparing posterior myotomy for achalasia cardia

Conditions: GERD

Summary: in this study, we will evaluate the incidence of reflux esophagitis between two different techniques of posterior per-oral endoscopic myotomy (poem) i.e. conventional poem versus oblique/ sling fiber sparing poem. this is a randomized trial where the patients with idiopathic achalasia will be randomized in two groups in 1:1 fashion into groups.

in this randomized trial, patients with idiopathic achalasia will undergo poem using two techniques as follows. in the first technique, a conventional posterior poem will be performed where the sling or oblique fibers will not be spared during poem. sling or oblique fibers will be recognized using the configuration of fibers below the gastroesophaeal junction and by identifying the border between the sling fibers and the circular fibers which is formed by the penetrating vessels. in the second group (oblique fiber group), the sling fibers will be selectively spared and only the circular fibers will be spared. the other steps of the poem procedure will be the same as described in the standard technique of poem. these include submucosal injection of saline mixed with indigo carmine dye, mucosal incision, submucosal tunneling using triangular knife in spray coagulation mode (effect 2, watts 50), myotomy extending upto 2-4 cm below the gastroesophageal junction and the closure of mucosal incision using endoclips. post poem management: all the patients will be kept nil per oral for about 24-hours after the procedure. a timed barium swallow will be performed the next day and oral liquids will be started. a soft puried diet will be started from day 3 onwards. oral proton pump inhibitors (ppis) equivalent to 40 mg of pantoprazole per day will be prescribed to all the patients unless a contraindication exists. follow-up: the first evaluation will be performed at 2-months after poem. during this evaluation, the following parameters will be recorded: symptom relief, reflux symptoms, and esophageal acid exposure. ppis will be stopped for 1-2 weeks prior to the evaluation of gerd. subsequent evaluation will be at 6-months for reflux symptoms and symptoms of achalasia using eckardt scores.

Eligibility criteria:
inclusion criteria: 1. patients with type 1 and 2 achalasia with eckardt score \>3 (0-12 scale achalasia). 2. patients with age 18-75 years. 3. patients who are treatment naïve or have a history of pneumatic balloon dilatation. 4. patients who are willing and able to comply with the study procedures and provide written informed consent form to participate in the study exclusion criteria: 1. patients with type 3 achalasia cardia or any other esophageal motility disorder, 2. patients who have undergone previous surgery of the esophagus or stomach, 3. patients with active severe esophagitis, 4. patients with large lower esophageal diverticula, 5. patients with large ( \> 3cm ) hiatal hernia, 6. patients with sigmoid oesophagus,
pilot study to evaluate if contrast enhanced ultrasound (ceus) can predict treatment response in triple negative breast cancer (tnbc) patients receiving combined chemotherapy and immune checkpoint inhibitors (ici).

Conditions: Breast Cancer; Contrast Enhanced Ultrasound

Summary: to find out if contrast enhanced ultrasound (ceus) can be used to determine if patients receiving combined ici therapy for triple negative breast cancer (tnbc) are responding to treatment earlier than standard of care mr or ct.


Eligibility criteria:
inclusion criteria: * willingness and ability to sign and date the study-specific informed consent form. * stated willingness to comply with all study procedures and attend all study visits to the best of his or her ability for the duration of the study. * age greater than 18yo. * stage i-iii tnbc or stage iv tnbc with intact breast primary. * planned combined ici therapy as per soc by treating oncologist. exclusion criteria: * other clinical trials are not excluded but participation must be cleared with the other clinical trial pis. * patients not suitable to undergo contrast enhanced ultrasound (i.e., pregnant women, known allergy to eggs, or a past allergic reaction to sonographic contrast or its components, such as polyethylene glycol (peg))

Keywords: breast cancer contrast enhanced ultrasound
echo vs. egdt in severe sepsis and septic shock

Conditions: Severe Sepsis; Septic Shock

Summary: echocardiography (cardiac ultrasound) is being used more often in the critical care setting for management of severe infection (septic shock). early studies show echocardiography to be useful in these patients, but at this time, there are no good clinical trials to justify its use. our study goals/objectives are as follows: 1. to conduct an unblinded, two-group randomized controlled clinical trial to compare an echocardiography-guided resuscitation protocol with an early goal directed therapy (egdt) protocol in patients with severe sepsis or septic shock. 2. demonstrate that a sepsis treatment protocol using transthoracic echocardiography and other non-invasive assessments of cardiac output will result in more rapid resolution of septic shock compared to invasive egdt. 3. demonstrate patients receiving the non-invasive echocardiography protocol will receive less administration of intravenous fluid.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * suspected infection * two or more systemic inflammatory response syndrome (sirs) criteria * white blood cell count less than 4,000 per mm3, greater than 12,000 per mm3, or differential with greater than 10% immature forms * heart rate greater than 90 beats per minute * respiratory rate greater than 20 breaths per minute or paco2 less than 32 mmhg * temperature less than 36°c or greater than 38°c * evidence of refractory hypoperfusion attributed to sepsis (one or more of the following): * systolic blood pressure less than 90 mmhg despite an intravenous fluid challenge of at least 30ml/kg (a portion of this may be albumin equivalent) * blood lactate level at least 4 mmol/l. * intention to place an arterial catheter. * intention to place a central venous catheter. exclusion criteria: * known pregnancy * requirement for immediate surgery * hypotension attributed to alternative cause * treating physician deems the patient is moribund * treating physician deems aggressive care is unsuitable * contraindication to central venous catheterization or arterial catheterization * advanced directives restricting implementation of the protocol * significant pathology of the chest or abdominal wall that would make transthoracic echocardiography impossible (burns, chest trauma, etc.) * children under the age of 18 will not be included in this study

Keywords: echocardiography egdt sepsis